FDA Advisory Panel Votes Against Blanket Booster but for Third Shot for Elderly, Those at High Risk of Severe COVID-19


Committee's two votes are only recommendations but a narrower booster emergency use authorization now seems likely.

An FDA advisory voted unanimously in favor of a narrower endorsement of booster shots of the Pfizer COVID-19 vaccine after voting 16-2 against a broader recommendation that would have included everyone 16 years and older.

The second vote on the narrower question endorsed a third shot of the Pfizer vaccine for those 65 and older and at higher risk of suffering a serious case of COVID-19.

The committee was also unanimously in favor a booster short for healthcare workers and others at high risk of occupational exposure to COVID-19, although that result was in a poll of the committee and not a formal part of the questions they voted onl

The committee's vote was closely watched for many reasons, chief among them because it figured into the high-stakes question of whether the FDA (and CDC) would go along with the Biden administration's push for a booster shots to start next week.

The vote of the FDA committee of outside experts — known as the Vaccines and Related Biological Products Advisory Committee — is not binding but the agency is expected to follow its recommendations. CDC has a separate committee, called the Advisory Committee on Immunization Practices, that sets the federal government's official vaccine recommendations.

Reaction to the committee votes among the experts who tweet about COVID vaccination was, by and large, favorable.

“The vote question was set up to fail, calling for a blanket approval for all age 16+ (related to aggressiveness Pfizer EUA request)," tweeted Topol. "How could that possibly be voted for in favor when such broad data do not exist anywhere? Of course the vote was 16 to 3 against." (Topol got the tally of the first vote slightly wrong).

Later, he said the votes were a "very good outcome for this FDA Advisory Committee following what data are available.

Ashish Jha, dean of the Brown University’s School of Public Health who has emerged as an influential voice on COVID-19, tweeted that data for higher risk people (those older 60 and those with multiple chronic diseases) is compelling but "data for 16 to 59-year olds getting booster is meh.” Jha called the unanimous vote for those 65 and older and at high risk a “good result, clearly consistent with the evidence and this outcome should never have been in doubt.”

Leana Wen, a former Baltimore health commissioner and a CNN medical analyst, tweeted that the committee came to "reasonable middle-ground decision."

Pfizer has argued that data show that protection from its two-shot vaccine wanes. The meaning of evidence from Israel, where a booster shot has been used, was debated by FDA advisory committee.

Two top FDA vaccine officials, Marion Gruber and Philip Krause, were among the authors of a Lancet review published on Monday that said current evidence didn't support booster shots while acknowledging that may eventually be necessary. Part of their argument is that even if antibody levels fall off, there are other parts of the immune response that will protect people, especially against a serious case of COVID-19.

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